Professional Documents
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Kinnison, Chapter 17
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Quality Audit
Why it is needed:
ISO 9001, 8.2.2 Internal audit
Definition: A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are suitable to achieve objectives.
--- ISO10011(Guideline for Quality System Auditing)
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Audits carried out by the Organization on its own systems (e.g. Internal Audit by QA unit) Audits carried out by the Customer on the Organization prior to or after contract placement.(e.g. by Government QA unit) Audits carried out by independent accredited organizations
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To confirm compliance with the rules. To ensure that the rules are implemented in an effective manner. To identify the system is applicable to the overall objectives of the organization To decide whether future contracts can be awarded; or To determine whether existing contractual performance is satisfactory. Mainly for the purpose of granting or to confirm continuation of (for ongoing surveillance audit) ISO9001 certification.
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Four workstations perform a job, and an inspector measures the parts. The measurements are plotted on a single control run chart for SPC. Does it conform to ISO?
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Personnel performing work affecting product quality shall be competent Personnel shall be competent on the basis of appropriate education.
Personnel shall be competent on the basis of appropriate training. Personnel shall be competent on the basis of appropriate skills. Personnel shall be competent on the basis of appropriate experience.
Does your organization ensure that the people who influence product quality are competent? Do you ensure that personnel have the right education? Do you ensure that personnel have the right training? Do you ensure that personnel have the right skills? Do you ensure that personnel have the right experience?
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ISO 9001
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a better spirit amongst employees; a greater degree of internal control; a reduction of scrap, rework and customer returns; a better company image; acceptance of the ISO 9000 quality system by major customers; easier retention of existing customers; a reduction in the loss of business; a gain in the area of new business a fall in the quality related costs; greater cost effectiveness
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Instance of non-conformance to the reference Quality System Standard. Instance of non-conformance to documented working practices
Non-Compliance Report, or Non-Conformance Report, or Corrective Action Request, or Discrepancies
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Drawing DT132 Issue E in use in workshop area, latest issue according to central register is F.
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Supplier invites bids from several certification bodies. Contract with a certification body based on price, reputation, and competence in the suppliers business area. Certification body makes thorough study (audit) of the suppliers rules, practices, organization, documentation, and so on, and raises nonconformance notes on aspects which are not up to ISO 9001. When the supplier has shown that the non conformances are corrected, the certification body issues a certificate saying that the supplier fulfills the requirements of ISO9001. Thereafter, the certification body will regularly (e.g., twice a year) make follow-up audits to check that the certificate is still valid. The certificate expires after three years, when a new certificate must be issued.
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It doesn't matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world. ISO does it by specify only the Whats but not the Hows
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preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
How does the shipper avoid the spread of dirt and contamination during shipment?
How does the chicken truck assure that temperature limit do not exceed?
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